An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true
for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well
as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic
drugs or biological agents, the overall tumor response rate remains basically unchanged.
S-1 is a new generation oral fluoropyrimidine that combines Tegafur
(5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of
5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits
5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium
(Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3
compounds is designed to achieve enhanced antitumor activity while decreasing
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the
efficacy and safety of single agent S-1 as 2nd line therapy for patients with advanced
NSCLC. The 3 stages of this study correspond to a futility stage (stage 1), a decision stage
(stage 2), and a stage for improvement of precision of ORR (stage 3).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)
Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Tumor assessmentswill be obtained at baseline and at the end of every even cycle
Fabio Benedetti, MD
Taiho Pharma USA, Inc.
United States: Food and Drug Administration